FDA.reportPublic FDA data

MAUDE MDR 4680379

MDR report key
4680379
Report number
8010762-2015-00348
Event key
0
Event type
3
Date of event
2015-03-07
Date received
2015-04-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHAEL CAMPBELL
Address
KEHLER STRABE 31 RASTATT 76437 GM
Phone
222-222-2229
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1QUADROX-I PAD. MIT RESERVOIRDTNMAQUET CARDIOPULMONARY AGDTN70105.0111VKMO 3000092115032R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-080

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PERFUSIONIST WAS ASSEMBLING THE CIRCUIT AND AT THE TIME OF CONNECTING TO THE QUADROX-I PAEDIATRIC OXYGENATOR AND FOUND THAT THE ARTERIAL OUTLET WAS COMPLETELY DETACHED FROM THE OXYGENATOR. THE PERFUSIONIST HAS REQUESTED TO REPLACE THE DEFECTIVE ON ASAP NO CONSEQUENCES TO THE PT WERE REPORTED. (B)(4).

N

Patient 1

MAQUET CARDIOPULMONARY HAS REQUESTED THE PRODUCT IN QUESTION FOR EVAL. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN NEW INFO BECOMES AVAILABLE.

N

Patient 1

THE MANUFACTURER WAS INFORMED THAT THE PRODUCT IN QUESTION WILL NOT BE AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR), THAT WERE CREATED DURING THE PRODUCTION OF THE DEVICE IN QUESTION, WAS PERFORMED AND NO DEVIATIONS COULD BE FOUND. THE PRODUCT IN QUESTION MET ALL SPECIFICATIONS AT THE TIME FOR FINAL PACKAGING AND RELEASE. BASED ON THE AVAILABLE INFORMATION TO THE MANUFACTURER AT THIS TIME AND WITHOUT THE POSSIBILITY TO EVALUATE THE PRODUCT IN QUESTION, A MALFUNCTION OF THE DEVICE CANNOT BE CONFIRMED.